Back to resultsMSCs For Treatment of Azoospermic Patients
Primary Purpose
Male Infertility
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring Azoospermia, Spermatogonial Arrest, Maturation Arrest.
Eligibility Criteria
Inclusion Criteria:
- All Non obstructive Azoospermic Patients.
- Azoospermic Patients due to Administration of Chemo/Radiotherapy.
Exclusion Criteria:
- Patients with Testicular Cancer.
- Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
Sites / Locations
- Al Azhar University , School of Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Laboratory and Clinical
Arm Description
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis.
Outcomes
Primary Outcome Measures
All Cases Improvement
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
Secondary Outcome Measures
All Cases Fertility Improvement
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.
Full Information
NCT ID
NCT02025270
First Posted
December 13, 2013
Last Updated
February 28, 2023
Sponsor
Al-Azhar University
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT02025270
Brief Title
MSCs For Treatment of Azoospermic Patients
Official Title
Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2012 (Actual)
Primary Completion Date
October 15, 2016 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
Collaborators
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.
Detailed Description
Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Azoospermia, Spermatogonial Arrest, Maturation Arrest.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laboratory and Clinical
Arm Type
Other
Arm Description
60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis.
Intervention Type
Biological
Intervention Name(s)
Stem Cells
Other Intervention Name(s)
Stem Cell Dose, 3-5 Million Autologous MSCs Injected into rete testis.
Intervention Description
60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
Primary Outcome Measure Information:
Title
All Cases Improvement
Description
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.
Time Frame
One Year (12-Month)
Secondary Outcome Measure Information:
Title
All Cases Fertility Improvement
Description
Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potency.
Time Frame
One Year (12-Month)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All Non obstructive Azoospermic Patients.
Azoospermic Patients due to Administration of Chemo/Radiotherapy.
Exclusion Criteria:
Patients with Testicular Cancer.
Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taimour M Khalifa, MD Professor
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sayed Bakry, PhD
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Saad Moneer, MSc
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Kadeh, MSc
Organizational Affiliation
Al-Azhar University
Official's Role
Study Chair
Facility Information:
Facility Name
Al Azhar University , School of Medicine
City
Cairo
ZIP/Postal Code
11884
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
MSCs For Treatment of Azoospermic Patients
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